Nucleic Acid Techologies
For highly sensitive and specific clinical & molecular diagnostic tests using PCR & NextGen Sequencing
APPLYING NEXTGEN NUCLEIC ACID TECHNOLOGIES.
IMPROVING HUMAN HEALTH.
Aegea Biotechnologies, Inc. is an innovation-driven, core technology company. We believe in the power of our science to transform several large markets----life science, diagnostics, genomics, next generation sequencing (NGS), and therapeutics. We are developing a series of reagents, research kits and in-vitro diagnostic (IVD) products for molecular analysis based on novel, patented and proprietary nucleic acid chemistries and methodologies.
AEGEA’s patented technologies, including its jointly assigned “Switch-Blocker” technology for highly sensitive rare mutation detection, give AEGEA’s kits the potential to truly disrupt the multi-billion dollar RUO (Research Use Only) and IVD molecular analyses segments. AEGEA's kits are designed to deliver assay and test results with unprecedented sensitivity and specificity--quickly and using established assay formats, instrumentation and reagents. In addition , AEGEA offers custom solutions, including assay development and adaptation of its technologies for different platforms, to various types of businesses, including pharmaceutical and biotech companies, diagnostics companies, DNA sequencing companies, and others.
AEGEA has a total of 11 issued US patents related to nucleic acid technologies, plus foreign equivalents. One of AEGEA’s patents for rare mutation detection is already validated and in clinical use in identifying biomarkers in cancer patients. More than 15,000 patient samples have been analyzed with a publicly listed (NASDAQ) company.
MOLECULAR DIAGNOSTICS (MDx)
AEGEA's patented "Switch-Blocker" constructions are important products arising from our Selector Technology. "Switch-Blocker" constructions address the most urgent priorities of the molecular diagnostics market, which heavily relies on nucleic acid-based technologies for sample preparation, nucleic acid target capture, amplification, detection and analysis. The driving factors of the molecular diagnostics market are better, faster, less expensive assays combined with point-of-care, point-of-use, multiplexing, and quantitative applications.
By definition, molecular diagnostic assays detect nucleic acid (RNA or DNA) of disease agents in test samples, such as blood, tissue, bodily fluids or swabs. PCR (polymerase-chain-reaction) is used to amplify selected sections of DNA or RNA for molecular diagnostic assays. PCR methodologies have many applications in the life science research, MDx, Next Generation Sequencing (NGS), and clinical diagnostic markets. The global PCR market is expected to reach $11.5 billion by 2024. AEGEA’s patented next generation nucleic acid technologies have several applications in this large and growing PCR market. AEGEA's patented "Switch-Blocker" constructions can be used to detect rare mutations associated with cancer and other diseases. In combination with Q-PCR, the "Switch-Blocker" technology can be used to detect extremely rare genetic events at a prevalence of less than 0.01%, even in a vast background of complex genomic wild-type/normal DNA. This elevates the molecular diagnostics assays to a new level of sensitivity in a high throughput, relatively inexpensive format that can be used to make better, more informed clinical and patient decisions.
NEXTGEN SEQUENCING (NGS)
AEGEA’s technical solutions and intellectual property portfolio are also directly applicable to NextGen Sequencing (NGS). Thanks to huge advances in NGS technology and instrumentation, including dramatically increased speed and reduced cost, the application of NGS to MDx is increasingly attractive and anticipated.
The NGS market dynamics are driven by ease of use, greater automation, and the ability to use less skilled labor to perform an assay whether automated or manual. These factors are being incorporated into next generation sequencing, particularly in the areas of biomarker discovery, multiplexing and NGS library preparation. AEGEA technologies are being applied in combination with NGS to enable multiplexed MDx assays that provide high sensitivity results across a broad range of medically significant target sequences for a variety of clinical indications.
The real-time PCR market, which includes kits, fluorescent detection methods and instrumentation, is growing rapidly and is an increasingly important segment of the total PCR market. The PCR market includes a combination of instrument, reagents, and software analysis tools.
These opportunities provide a unique combinations of technologies that improve both MDx assay capabilities and, at the same time, facilitate improvements to whole transcriptome and whole genome amplification, library construction, and amplification improvements associated with NGS. AEGEA's "Switch-Blocker" technology has already been used to increase the sensitivity of rare mutations associated with cancer by more than 20,000 fold.
AEGEA's patented blocking approach suppresses wild-type DNA amplification, while allowing specific amplification of mutant alleles
Validated and tested in over 15,000 patient samples through a cross-license with a public, NASDAQ-listed company (Biocept, Inc). ctDNA platform uses a real-time PCR-based approach, coupled with DNA sequencing, to identify cancer-associated genetic mutations within circulating tumor DNA.
AEGEA's Selector Technology can be used to improve virtually any platform or assay format where ultra-sensitive and specific performance is desired, including platforms that have been recently approved for COVID-19 testing (both lab and point of care settings). In addition to using the technology to give extremely high sensitivities and specificities, the Selector Technology can be combined with any of the major assay formats—taqman, ARMS, etc—to dramatically increase performance
LYLE J. ARNOLD, PH.D.
Founder, President & CSO
Dr. Arnold is a biotechnology executive, entrepreneur, and developer of innovative technologies covering therapeutics, molecular diagnostics, and genomics. He currently serves as President and Founder of Aegea Biotechnologies as well as Sr. VP of R&D, and CSO at Biocept. Dr. Arnold has held senior scientific and management positions at Molecular Biosystems (co-founder), Genta, Synteni, Incyte Genomics, Oasis Biosciences (co-founder), and Gen-Probe (now Hologic). Dr. Arnold is an inventor or co-inventor on 54 issued U.S. patents and more than 200 issued and pending patents worldwide. He is the principal inventor of the chemiluminescent Hybridization Protection Assay (HPA) and associated technologies core to Hologic assays that generate more than $700M in product revenue annually. Dr. Arnold received a B.S. in Chemistry from the University of California at Los Angeles and a Ph.D. in Chemistry/Biochemistry from the University of California at San Diego.
Mr. Domonici has over 30 years of experience in operating revenue-generating medical device and medical diagnostics companies. He previously served as President, Lab Systems Division, Roche Diagnostics (Boehringer Mannheim). Mr. Domonici also held the Chief Operation Officer position at Cholestech. He is an entrepreneur and has founded multiple start-up companies, including Microgenics. Mr. Domonici earned his B.S. from Otterbein University.
STELLA M. SUNG, PH.D.
Dr. Sung is a life Science/biotech executive with 25 years of experience in both operating and venture capital roles. Dr. Sung has been a "C-level" executive (CEO/CBO) at multiple life science companies, including ImmunoActiva, Tauriga Sciences, Avita Medical, PliCare Therapeutics and Cylene Pharmaceuticals. Dr. Sung has negotiated numerous transactions, agreements, and partnerships, and she has structured and led financings. She also has built companies as a venture investor. Dr. Sung has a successful track record as a General Partner or Managing Director at several venture firms, including Oxford Bioscience Partners, Coastview Capital and Pearl St. Venture Fund, where her experience also includes ten Board of Directors positions, including five as Chairperson of the Board. Dr. Sung received her Ph.D. in chemistry from Harvard University, where she was a National Science Foundation Pre-Doctoral Fellow, and her B.S. in chemistry from The Ohio State University, Phi Beta Kappa.
NORMAN NELSON, PH.D.
VP, Operations & Development
Dr. Nelson is a PhD scientist with 32 years experience in the FDA-regulated Molecular Diagnostics industry. Expert in Next Generation Sequencing, including in-house experience with Illumina, Ion Torrent & Pacific Biosciences platforms and associated workflows. Proven track record in innovation and core technology conception, reduction to practice and implementation (co-invented and played a key role in commercialization of multiple technologies, many of which are core to Gen-Probe products that generate >$700MM annual revenue) and broad expertise and experience in intellectual property protection. Ph.D. from UCSD and BS (Chemistry) from California Institute of Technology.
Collectively, the AEGEA executive management team has:
>100 years of biotechnology experience
>75 issued US patents and >200 issued and pending patents worldwide
Led and managed >15 biotechnology and genomics companies
Helped create >$7 billion in value in associated companies